Role of Opioids in Epidural Solutions

Postoperative Pain Clinical Trial

Official title:

The Role of Epidural Opioids in Pain Management After Abdominal Surgery in Adult Patients - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251962
• Other study ID #: 0489-19-TLV
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: March 2, 2022

Study information

• Verified date: April 2023
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is unclear whether addition of opioids to epidural solutions for postoperative analgesia is beneficial. In this multicenter randomized double-blinded trial, we aim to test the primary hypothesis that epidural solutions containing only bupivacaine are as effective as solutions containing both bupivacaine and fentanyl in promoting analgesia in patients recovering from open abdominal surgery. We also aim to assess the incidence of epidural-induced hypotension, the difference in patient-reported opioid side-effects between the two groups. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to substantially reduce the amount of opioids patients receive during their postoperative recovery, and potentially decrease the associated high incidence of opioid adverse effects in post-surgical patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Written informed consent

2. 18-85 years old

3. Undergoing open abdominal surgery (including colorectal, intestinal, gastric, pancreatic, hepatobiliary, urological, or gynecological surgery)

4. For which a clinical decision has been made to provide epidural analgesia preoperatively and extending to the post-operative period

5. Anticipated hospitalization of at least 2 nights

Exclusion Criteria:

1. Known allergy to bupivacaine or fentanyl

2. Chronic liver disease, defined as cirrhosis, portal hypertension, or variceal bleeding

3. Patients under chronic alpha-blocking agents for hypertension

4. Clinical contraindications to epidural introduction, as judged by the anesthesia provider (thrombocytopenia, un-interrupted anticoagulation, clinically-significant atrio-ventricular conduction block, etc.)

5. Pregnant women

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacaine
epidural solution containing bupivacaine 0.1% in normal saline
• Fentanyl
Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline

Locations

Country	Name	City	State
Israel	Division of Anesthesia, Pain and Critical Care, Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Israel Society of Anesthesiologists

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recovery of gastrointestinal function	Time to first postoperative bowel movement	Throughout the postoperative hospital stay, up to 30 days
Other	Opioid-related side effects	A composite of opioid-related side-effects as measured by the Opioid-Related Symptom Distress Scale (OR-SDS) questionnaire (higher scores represent more side-effects and related distress, scores are given on multiple dimensions)	48 postoperative hours
Primary	Postoperative analgesia	A joint outcome of the difference in average pain score and a ratio of opioid consumption (in mg morphine equivalents) between the 2 study groups	48 postoperative hours
Secondary	Clinically significant postoperative hypotension	Number of participants experiencing a composite of use of IV fluid boluses prescribed for hemodynamic support; sympathomimetic drugs administration; and holding or early discontinuation of the epidural infusion in order to recover blood pressure.	48 postoperative hours